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Drug

Tralokinumab

Approved · EMA
ClassInterleukin-13 inhibitorEmerging researchLate-stage developmentRising momentum

Also known as Adbry.

RxNorm2589225ChEMBLCHEMBL1743081ATCD11AH07UNIIGK1LYB375A
3
Research papers
1
Active clinical trials
Interleukin-13
Primary target
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Utilization of a Cutaneous Therapy In Situ Microdevice

Clinical trial2026-06-03Results expected Q2 2030 · ClinicalTrials.gov

A Single (Assessor) Blinded, Randomized, Parallel-group, Monotherapy Trial to Evaluate the Pharmacokinetics and Safety of Tralokinumab in Children (Age 6 to <12 Years) With Moderate-to-severe Atopic Dermatitis

Clinical trial2026-04-29Completed · ClinicalTrials.gov

A Single-Center, Open-Label Study to Evaluate Tralokinumab in Atopic Dermatitis Subjects Who Experienced Inadequate Response on Dupilumab

Clinical trial2026-01-13Terminated · ClinicalTrials.gov

A Phase 3b, Interventional, Adaptive, Clinical Trial to Evaluate the Efficacy and Safety of Tralokinumab 300 mg Every Second Week Monotherapy Compared With Placebo in Subjects With Moderate-to-severe Atopic Hand Eczema Who Are Candidates for Systemic Therapy

Clinical trial2025-09-22Completed · ClinicalTrials.gov

A Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Effect of Tralokinumab on Vaccine Antibody Responses in Adults With Moderate-to-severe Atopic Dermatitis Who Are Candidates for Systemic Therapy

Clinical trial2025-03-11Results posted · ClinicalTrials.gov

A Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre Trial to Evaluate the Efficacy, Safety, and Tolerability of Tralokinumab Monotherapy in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) Who Are Candidates for Systemic Therapy

Clinical trial2025-03-11Results posted · ClinicalTrials.gov

A Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre, Phase 3 Trial Investigating the Efficacy, Safety, and Tolerability of Tralokinumab Administered in Combination With Topical Corticosteroids to Adult Subjects With Severe Atopic Dermatitis

Clinical trial2025-03-11Results posted · ClinicalTrials.gov

A Randomised, Double-blind, Placebo-controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Tralokinumab Monotherapy in Subjects With Moderate to Severe Atopic Dermatitis Who Are Candidates for Systemic Therapy

Clinical trial2025-03-11Results posted · ClinicalTrials.gov

Efficacy and Safety of Tralokinumab in Adolescents With Moderate to Severe Atopic Dermatitis: The Phase 3 ECZTRA 6 Randomized Clinical Trial.

Research2023-06-01JAMA dermatology

Approval: Adtralza (EMA)

Regulatory2021-06-17EMA

Tralokinumab for moderate-to-severe atopic dermatitis: results from two 52-week, randomized, double-blind, multicentre, placebo-controlled phase III trials (ECZTRA 1 and ECZTRA 2).

Research2020-12-30The British journal of dermatology

Tralokinumab for moderate-to-severe UC: a randomised, double-blind, placebo-controlled, phase IIa study.

Research2014-10-10Gut

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Tralokinumab
Aliases & brands
Adbry
RxNorm CUI
2589225
ChEMBL ID
CHEMBL1743081
ATC codes
D11AH07
UNII
GK1LYB375A
Primary mechanism
Interleukin-13 inhibitor
Regulatory jurisdictions
ema

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Interleukin-13
IL13 · P35225
INHIBITORInterleukin-13 inhibitor

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2021-06-17
Latest approval
2021-06-17
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2021-06-17Approval
Approval: Adtralza (EMA)

Indication: Adtralza is indicated for the treatment of moderate to severe atopic dermatitis in adult and adolescent patients 12 years and older who are candidates for systemic therapy.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

23 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
23
registered trials across all phases
LATEST COMPLETION 2026
1
Active studies
1
Recruiting
13
Late-stage (III+)
20
Completed
2
Discontinued
PHASE DISTRIBUTIONn = 23
Phase 13Phase 27Phase 311Phase 42

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Utilization of a Cutaneous Therapy In Situ Microdevice

Not yet recruitingPH IVUniversity of California, San Franciscon=102030

A Single-Center, Open-Label Study to Evaluate Tralokinumab in Atopic Dermatitis Subjects Who Experienced Inadequate Response on Dupilumab

TerminatedPH IVPsoriasis Treatment Center of Central New Jerseyn=72026

A Phase 3b, Interventional, Adaptive, Clinical Trial to Evaluate the Efficacy and Safety of Tralokinumab 300 mg Every Second Week Monotherapy Compared With Placebo in Subjects With Moderate-to-severe Atopic Hand Eczema Who Are Candidates for Systemic Therapy

CompletedPH IIILEO Pharman=2352025

An Open-label, Single-arm, Multi-centre, Long-term Extension Trial to Evaluate the Safety and Efficacy of Tralokinumab in Subjects With Atopic Dermatitis Who Participated in Previous Tralokinumab Clinical Trials

CompletedPH IIIKey trialLEO Pharman=1,6722024

An Open-label, Single-arm, Phase 3 Trial to Evaluate the Efficacy and Safety of Tralokinumab Administered by an Autoinjector in Subjects With Moderate-to-severe Atopic Dermatitis

CompletedPH IIILEO Pharman=1362023

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Single (Assessor) Blinded, Randomized, Parallel-group, Monotherapy Trial to Evaluate the Pharmacokinetics and Safety of Tralokinumab in Children (Age 6 to <12 Years) With Moderate-to-severe Atopic Dermatitis

CompletedPH IILEO Pharman=282026

A Phase 3b, Interventional, Adaptive, Clinical Trial to Evaluate the Efficacy and Safety of Tralokinumab 300 mg Every Second Week Monotherapy Compared With Placebo in Subjects With Moderate-to-severe Atopic Hand Eczema Who Are Candidates for Systemic Therapy

CompletedPH IIILEO Pharman=2352025

An Open-label, Single-arm, Multi-centre, Long-term Extension Trial to Evaluate the Safety and Efficacy of Tralokinumab in Subjects With Atopic Dermatitis Who Participated in Previous Tralokinumab Clinical Trials

CompletedPH IIIKey trialLEO Pharman=1,6722024

An Open-label, Single-arm, Phase 3 Trial to Evaluate the Efficacy and Safety of Tralokinumab Administered by an Autoinjector in Subjects With Moderate-to-severe Atopic Dermatitis

CompletedPH IIILEO Pharman=1362023

Effects of Tralokinumab Treatment of Atopic Dermatitis on Skin Barrier Function

CompletedPH IIProf. Dr. Stephan Weidingern=162023

A Randomised, Double-blind, Placebo-controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Tralokinumab in Combination With Topical Corticosteroids in Japanese Subjects With Moderate-to-severe Atopic Dermatitis Who Are Candidates for Systemic Therapy

CompletedPH IIILEO Pharman=1062021

Research activity

3 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20152023
Major research themes2
Dermatitis, Atopic2Eczema2
Journals, researchers & institutions
Top journals
  • Gut1
  • JAMA dermatology1
  • The British journal of dermatology1
Leading researchers
  • Blauvelt A2
  • Simpson EL2
  • Wollenberg A2
  • Arlert P1
  • Bang B1
  • Bewley A1
  • Bouhnik Y1
  • Brandt W1
Leading institutions
free-text, unnormalised
  • Ludwig Maximilian University of Munich2
  • Oregon Health & Science University2
  • Oregon Medical Research Center2
  • AllerVie Health/Alabama Allergy & Asthma Center1
  • Catholic University and Fondazione Policlinico Universitario A. Gemelli1
  • Centre Hospitalier Universitaire1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.